The Effect of USG-Guided Coccygeal Nerve Block on Sacrococcygeal And/or Intercoccygeal Joint Injection for Coccydynia

NCT ID: NCT05683262

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2024-06-18

Brief Summary

Coccydynia refers to a significant pain, that does not radiate, in and around the coccyx region. This symptom is typically worsen while sitting, especially on hard surfaces, standing up from sitting position and standing for long time. The steroid and anesthetic injection to the sacrococcygeal, intercoccygeal joints and impar ganglions are the most commonly cited second line management option in the literatures for refractor cases. The coccygeal nerve blockade or radiofrequency ablation is also used for coccydynia especially for traumatic cases. The aim of the study is; to evaluate the efficacy of ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection in coccydynia and to investigate whether coccygeal nerve blockade has an additional contribution to this treatment.

Detailed Description

Coccydynia refers to a significant pain, that does not radiate, in and around the coccyx region. This symptom is typically worsen while sitting, especially on hard surfaces, standing up from sitting position and standing for a long time. There are several uncertainties with respect to the origin of etiology and the commonest factor for coccydynia is external and internal trauma such as falling, giving birth. Also there are idiopathic cases. The risk of coccydynia progression is higher in the female gender and when obesity is present. The morphology and hypermobility of coccyx are associated with coccydynia and degenerative changes in the intercoccygeal discs have been incriminated to be a cause of pain in 41% of idiopathic and 44% of traumatic coccydynia. The other causes such as infections, tumors such as chordoma, osteoid osteoma or notochordal cell tumors. The antero-posterior (AP) and lateral radiographs are primary imagining modality to rule out these conditions and also to investigate predisposing factors for coccydynia such as bony spicule, retroverted coccyx, subluxation or scoliosis of coccyx. The radiographs are also useful to find out any fracture or dislocation in cause of trauma. Angular mobility evaluation is done by dynamic imaging modalities and still mostly used method is dynamic radiographs which are performed in standing and seated position at the point of maximum pain. Magnetic resonance imaging (MRI) is used for chronic cases to identify most accurate diagnosis and to find exact irritation point and also for ruling out the infections and tumors. A wide range of treatment options have been described till date and conservative therapy such as heat, ice, seat cushions, topical anesthetic and oral/topical non-steroidal anti-inflammatory drugs and intrarectal/intravaginal manual manipulation is successful in %90 of cases. The second line management option for refractor cases is steroid and anesthetic injections however, site of injection is controversial. The sacrococcygeal, intercoccygeal joints and impar ganglions are the most commonly sites for injections cited in the literatures. The success rate of the sacrococcygeal and intercoccygeal joints injections are reported as 60% in most of the studies and the symptoms of nearly one third of the patients relapse within one year. The coccygectomy is an effective modality for these refractory cases but, postoperative complications lead to continue to search conservative treatments options. The innervation of coccyx posteriorly is mostly done by paired of coccygeal nerves and the posterior rami of fourth and fifth sacral nerves which are joining with coccygeal nerves. The coccygeal nerves innervate the coccygeal periosteum, sacrococcygeal joint and the skin over the coccyx. Pain occur at posterior region, after trauma such as falling or long time sitting may be elicited by coccygeal nerves. The coccygeal nerve emerges from the conus medullaris and pierces the posterior sacrococcygeal ligament while it descends in sacral canal. At the level of coccygeal cornu (CC), it is in the the subcutaneous layer and medial to the CC. Therefore coccygeal nerve blockade or radiofrequency ablation is also used for coccydynia especially for traumatic cases. Image guidance such as ultrasound (USG), fluoroscopy, computerized tomography (CT) provide visualization of the needle into the target and improves the accuracy of injections. The use of USG improve the identification of musculoskeletal structures and it spares the patient radiation exposure. It has advantage over the other modalities in that it is cost effective, portable and adapted in multiple disciplines and it has therapeutic safety.

In this study, it is planned to assessed the change of pain severity of the patients who had sacrococcygeal and/or intercoccygeal joint injection with/without coccygeal nerve block in our clinic due to the complaint of coccydynia resistant to conservative treatment methods, by applying the Numeric Rating Scale (NRS). Patients are asked to indicate rates of their pain on the day of presentation during palpation of coccyx, at the first sitting, sitting on soft and hard surface, standing up from sitting position, standing for long time, during defecation, sexual intercourse and menstrual cycle, and also 1 week, 4 weeks, 3 moths and 6 months after the injection for each. Participants are asked to indicate rates of their pain according to NRS during sitting, standing up from sitting position and on palpation of coccyx at the first hour of injection. The pain elicited by injection is also asked after one hour, to determine the effect of coccygeal nerve block which is applied before the sacrococcygeal and/or intercoccygeal joint injection. The second outcome measurement method is assessing the change of pain-free sitting time as a minute before the injection, and one hour, 1 week, 4 weeks, 3 moths and 6 months after the injection.The Oswestry Disability Index for patients with low back pain, Short Form-12 (SF-12) are applied to the participants before the procedure and, at the 1st month, 3rd months and 6 months after the treatment. In these ways, it is planned to evaluate the efficacy of sacrococcygeal and/or intercoccygeal joint injection and also to understand does any additive effect of coccygeal nerve blockade to this treatment approach.

Conditions

Coccyx Disorder; Coccygodynia; Coccyx Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection is applied to patients in this group

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection

Intervention Type: PROCEDURE

Ultrasound guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position with a pillow under the abdomen to flatten the lumbar curvature. Lower extremities should be internally rotated while feet are inverted to help flatten the gluteal region. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. Ultrasonography gel was applied on the probe and the probe was wrapped with a transparent thin sheath and cleaned with povidone iodine. Sterile gel is applied on the skin. The sacrococcygeal ligament, the sacrococcygeal and intercoccygeal joints were visualized. The sacrococcygeal and/or intercoccygeal joints were entered using the in-plane technique with a 23 gauge 6 cm long needle. When it was seen that the needle tip was inside the joint, 3 cc of 2% lidocaine + 1 cc betamethasone solution was injected.

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection with coccygeal nerve block

Ultrasound-guided coccygeal nerve blockade is done before the application of ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection to patients in this group

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided coccygeal nerve block

Intervention Type: PROCEDURE

Patients are placed in the prone position with a pillow under the abdomen. Lower extremities are internally rotated while feet are inverted. Injection site and the probe are cleaned thrice with povidone iodine %10 solution. Sterile gel is applied. The prob was placed on coccygeal cornu and the coccygeal nerve was visualized superomedial to the CC in the subcutaneous tissue layer. Hydrodissection was made by administering 5 ml of 5% dextrose + 1 ml of 2% lidocaine via an in-plane approach with a 23 gauge 6 cm long needle, targeting the short axes of the bilateral coccygeal nerves.

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection after coccygeal nerve block

Intervention Type: PROCEDURE

After the coccygeal nerve block, when the pain with palpation of the coccygeal region was reduced by at least 50%, the sacrococcygeal ligament, sacrococcygeal and intercoccygeal joints were visualized.The sacrococcygeal and/or intercoccygeal joints were entered using the in-plane technique with a 23 gauge 6 cm long needle. When the needle tip was inside the joint, 3 cc of 2% lidocaine + 1 cc betamethasone solution was injected.

Interventions

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection

Ultrasound guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position with a pillow under the abdomen to flatten the lumbar curvature. Lower extremities should be internally rotated while feet are inverted to help flatten the gluteal region. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. Ultrasonography gel was applied on the probe and the probe was wrapped with a transparent thin sheath and cleaned with povidone iodine. Sterile gel is applied on the skin. The sacrococcygeal ligament, the sacrococcygeal and intercoccygeal joints were visualized. The sacrococcygeal and/or intercoccygeal joints were entered using the in-plane technique with a 23 gauge 6 cm long needle. When it was seen that the needle tip was inside the joint, 3 cc of 2% lidocaine + 1 cc betamethasone solution was injected.

Intervention Type: PROCEDURE

Ultrasound-guided coccygeal nerve block

Patients are placed in the prone position with a pillow under the abdomen. Lower extremities are internally rotated while feet are inverted. Injection site and the probe are cleaned thrice with povidone iodine %10 solution. Sterile gel is applied. The prob was placed on coccygeal cornu and the coccygeal nerve was visualized superomedial to the CC in the subcutaneous tissue layer. Hydrodissection was made by administering 5 ml of 5% dextrose + 1 ml of 2% lidocaine via an in-plane approach with a 23 gauge 6 cm long needle, targeting the short axes of the bilateral coccygeal nerves.

Intervention Type: PROCEDURE

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection after coccygeal nerve block

After the coccygeal nerve block, when the pain with palpation of the coccygeal region was reduced by at least 50%, the sacrococcygeal ligament, sacrococcygeal and intercoccygeal joints were visualized.The sacrococcygeal and/or intercoccygeal joints were entered using the in-plane technique with a 23 gauge 6 cm long needle. When the needle tip was inside the joint, 3 cc of 2% lidocaine + 1 cc betamethasone solution was injected.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Aged 18-65 years

2. Patients who have coccygeal pain and have not benefited from conservative treatment

3. Be able to understand enough Turkish to complete the outcome questionnaire

4. Patients whose informed consent was obtained for participation in the study

Exclusion Criteria

1. Fibromyalgia

2. History of surgery for coccydynia

3. Pregnancy or breastfeeding

4. Inflammatory disease which effect the spine

5. Malignancy

6. Coagulation disorders

7. Infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fatih Sultan Mehmet Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aslinur Keles Ercisli, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Feyza Unlu Ozkan

Role: STUDY_DIRECTOR

Fatih Sultan Mehmet Training and Research Hospital

Locations

Farih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Sencan S, Edipoglu IS, Ulku Demir FG, Yolcu G, Gunduz OH. Are steroids required in the treatment of ganglion impar blockade in chronic coccydynia? a prospective double-blinded clinical trial. Korean J Pain. 2019 Oct 1;32(4):301-306. doi: 10.3344/kjp.2019.32.4.301.

Reference Type: BACKGROUND

PMID: 31569923 (View on PubMed)

Garg B, Ahuja K. Coccydynia-A comprehensive review on etiology, radiological features and management options. J Clin Orthop Trauma. 2021 Jan;12(1):123-129. doi: 10.1016/j.jcot.2020.09.025. Epub 2020 Sep 24.

Reference Type: BACKGROUND

PMID: 33716437 (View on PubMed)

Mitra R, Cheung L, Perry P. Efficacy of fluoroscopically guided steroid injections in the management of coccydynia. Pain Physician. 2007 Nov;10(6):775-8.

Reference Type: BACKGROUND

PMID: 17987101 (View on PubMed)

Datir A, Connell D. CT-guided injection for ganglion impar blockade: a radiological approach to the management of coccydynia. Clin Radiol. 2010 Jan;65(1):21-5. doi: 10.1016/j.crad.2009.08.007. Epub 2009 Oct 24.

Reference Type: BACKGROUND

PMID: 20103417 (View on PubMed)

Woon JT, Stringer MD. Clinical anatomy of the coccyx: A systematic review. Clin Anat. 2012 Mar;25(2):158-67. doi: 10.1002/ca.21216. Epub 2011 Jul 7.

Reference Type: BACKGROUND

PMID: 21739475 (View on PubMed)

Chen Y, Huang-Lionnet JHY, Cohen SP. Radiofrequency Ablation in Coccydynia: A Case Series and Comprehensive, Evidence-Based Review. Pain Med. 2017 Jun 1;18(6):1111-1130. doi: 10.1093/pm/pnw268.

Reference Type: BACKGROUND

PMID: 28034983 (View on PubMed)

Wu WT, Hsu YC, Chang KV, Ozcakar L. Ultrasound Imaging and Ultrasound-Guided Injection of the Coccygeal Nerve for Coccydynia. Am J Phys Med Rehabil. 2022 Jul 1;101(7):e108-e109. doi: 10.1097/PHM.0000000000001987. Epub 2022 Feb 23. No abstract available.

Reference Type: BACKGROUND

PMID: 35220319 (View on PubMed)

Other Identifiers

E-83041234-604.16.01-8011

Identifier Type: -

Identifier Source: org_study_id